SYNTHES AFS

K032534 · Synthes Spine · NQW · Apr 1, 2004 · Orthopedic

Device Facts

• Record ID: K032534
• Device Name: SYNTHES AFS
• Applicant: Synthes Spine
• Product Code: NQW · Orthopedic
• Decision Date: Apr 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes AFS is indicated for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Arch Fixation System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.

Device Story

Synthes AFS consists of pre-bent mini-plates and screws used in spinal surgery; plates feature central and end screw holes for bone attachment and allograft stabilization. Device functions as a buttress to prevent allograft expulsion or spinal cord impingement following laminoplasty. Used in lower cervical and upper thoracic spine (C3-T3). Operated by surgeons in clinical/OR settings. System integrates with previously cleared Synthes posterior cervical spine products.

Clinical Evidence

Bench testing only. Performance characteristics were compared to commercially available devices to support substantial equivalence.

Technological Characteristics

Commercially pure titanium (ASTM F67) plates; titanium alloy Ti6Al7Nb (ASTM F1295) screws. Pre-bent mini-plate form factor with screw holes for bone and allograft attachment. Designed for use with existing Synthes posterior cervical spine components.

Indications for Use

Indicated for patients undergoing laminoplasty in the lower cervical and upper thoracic spine (C3-T3) to secure bone allograft and prevent expulsion or spinal cord impingement.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• Plate, fixation, bone (K963741)
• Plate, fixation, bone (K961485)
• Plate, fixation, bone (K961497)
• Bone fixation Cerclage (K850631)

Submission Summary (Full Text)

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## APR = 1 2004

## 3.0 Summary of Safety and Effectiveness Information

| SPONSOR: | Synthes USA<br>1230 Wilson Drive<br>West Chester, PA 19380<br>[phone]<br>Contact: Susan Lewandowski |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Synthes Arch™ Fixation System (AFS) |
| CLASSIFICATION: | 21 CFR §888.3050: Spinal interlaminal fixation orthosis.<br>Product code: NQW |
| COMMON NAME: | Appliance, fixation, interlaminal |
| PREDICATE DEVICE: | Plate, fixation, bone:<br>K963741 – Howmedica Leibinger Inc.<br>K961485 – Howmedica Inc.<br>K961497 – Howmedica Inc.<br>Bone fixation Cerclage:<br>K850631 – Kirschner Medical Corp. |
| DEVICE DESCRIPTION: | The Synthes AFS is comprised of various sized, pre-bent mini-<br>plates that are designed to fit the anatomy of the vertebral arch<br>(i.e., between the pedicle and spinous process). The plates<br>have screw holes located at the center and both ends of the<br>plate to allow for attachment to the bone. The center hole in<br>the plate is used for attachment to bone allograft. The plates<br>are composed of commercially pure titanium which conforms to<br>ASTM F67.<br><br>The screws intended for use with the mini-plates are available<br>in a variety of lengths and diameter and are designed to match<br>the anatomical requirements. The screws are composed of<br>titanium alloy, Ti6Al7Nb, which conforms to ASTM F1295.<br><br>The Synthes AFS is designed to be used in conjunction with<br>the components that comprise previously cleared Synthes<br>posterior cervical spine products. |
| INTENDED USE: | The Synthes AFS is indicated for use in the lower cervical and<br>upper thoracic spine (C3-T3) after a laminoplasty has been<br>performed. The Arch Fixation System holds or buttresses the |

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K032534
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The first to the country of the complement of the former of the form and

allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.

- All components of the Synthes AFS are manufactured from MATERIAL: commercially pure titanium (ASTM F67) or titanium alloy Ti6Al7Nb (ASTM F1295).
PERFORMANCE Performance characteristics comparing the Synthes AFS to DATA: performance characteristics of commercially available devices were provided to support a determination of substantial equivalence.

The Synthes AFS implants are similar in design, material and BASIS OF performance to currently marketed orthopedic implants. The SUBSTANTIAL EQUIVALENCE: intended use of the product as a buttress plate is substantially equivalent to information presented on the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = 1 2004

Ms. Susan Lewandowski Project Manager, Regulatory Affairs Synthes (USA) 1230 Wilson Drive West Chester, Pennsylvania 19380

Re: K032534

Trade/Device Name: Synthes Arch™ Fixation System (AFS) Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: NOW Dated: January 2, 2004 Received: January 5, 2004

Dear Ms. Lewandowski:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Ms. Susan Lewandowski

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Mark A. Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement 2.0

Page 1 of 1

510(k) Number (if known): __ _________________________________________________________________________________________________________________________________________________

Synthes Arch™ Fixation System (AFS) Device Name:

## Indications:

The Synthes Arch™ Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Arch™ Fixation System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

R. Mark N. Milliman

Division of General. Restorative. and Neurological Devices

510(k) Number K032534